BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3802340 · Received May 9, 2014

    Report

    Report Number
    2124215-2014-10484
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM (ER) DUE TO DIZZINESS AND SYNCOPE FOR AN UNKNOWN REASON. THE DEVICE WAS REPROGRAMMED BY SHORTENING THE ATRIAL VENTRICULAR (AV) DELAY. HOWEVER DURING AN OFFICE VISIT FOLLOWING THE ER VISIT THE PACEMAKER WAS REPROGRAMMED BACK TO A LONGER AV DELAY AND THE AV SEARCH FEATURE WAS PROGRAMMED ON. APPROXIMATELY ONE AND A HALF MONTHS LATER THE PATIENT WAS SEEN IN THE ER AGAIN WITH THE SAME SYMPTOMS. IT WAS NOTED THAT THE PATIENT HAS RETROGRADE CONDUCTION AT 200 SO THE POST-VENTRICULAR ATRIAL REFRACTORY PERIOD (PVARP) WAS REPROGRAMMED. THE PATIENT ALSO HAS SECOND DEGREE HEART BLOCK TYPE TWO. WHILE SITTING IN THE HOSPITAL, IT WAS OBSERVED THAT WHEN THE AV SEARCH WAS OCCURRING THE PATIENT FELT SOME OF THE SAME SYMPTOMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED PROGRAMMING OPTIONS. SUBSEQUENTLY THE AV SEARCH FEATURE WAS PROGRAMMED OFF AND THE AV DELAY WAS SHORTENED ONCE AGAIN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280790 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K064

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Life Threatening| R 4470| K064| 4469